Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior DirectorProject Management
Deborah – Senior Manager Human Resources
Martin Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development and Technology
Pawel – Senior Manager Statistical Programming
Jobs at Parexel
Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.
The Site Activation Partner II (SAP II) is responsible for leading or supporting operational activities. from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.
Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval.
Register investigator sites in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to IIP essential documents components, study contracts contacts, clinical supply shipment information, payment information, Investigator Review Board (IRB) submission and status.
Take the lead to resolve issues or concerns and timely escalation of issues where applicable.
Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required timelines.
Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation.
Take the Lead and Coordinates the compilation of the Central IRB package and submissions to approval of the study .
Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent).
Support investigators sites with local IRB workflow from preparation, submission through approval .
Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
Initiate and coordinate activities and essential documents management with the investigator’s sites (post site initiation visit (SIV)) during study conduct towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572 revisions, Ethics Committee annual approvals.
Responsible for timely filing of documents to Trial Master File and other systems and assist with periodic quality review of study files for accuracy and completeness.
Skills and Education:
School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred.
Minimum 6 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset.
Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
Must be fluent in Local language and in English.
For individuals based in Canada: Bilingualism (French, English) is an asset.
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
Good technical skills and ability to learn and use multiple systems .
Experience working in a global environment.
Experience in working in more than 1 country is an asset.
Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes.
Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach.
Proven ability to work independently and also as a team member.
Ability to organize tasks, time and priorities, ability to multi-task .
Understand basic medical terminology, GCP requirements and proficient in computer operations.
It has been brought to our attention that there has been fraudulent activity by scammers attempting to represent themselves as Parexel employees or recruiters. These individuals are attempting to reach potential job seekers through online chat interviews and sending false offer letters, representing Parexel without our consent. If you’re concerned that you’ve been contacted by an unauthorized Parexel recruiter or employee, please notify Jobs@Parexel.com. You may also report suspicious fraudulent activity to your local law enforcement agency or the FBI. Thank you.